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Shane Bailey Email & Phone Number
Associate Director of Global Quality and Regulatory Affairs
at
Bend Bioscience
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✓ Verified Jun 2026
3 data sources
Profile completeness 86%
Current company
Role
Associate Director of Global Quality and Regulatory Affairs
Location
Tampa, Florida, United States
Who is Shane Bailey? Overview
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Quick answer
Shane Bailey is listed as Associate Director of Global Quality and Regulatory Affairs at Bend Bioscience, based in Tampa, Florida, United States. AeroLeads shows a matched LinkedIn profile for Shane Bailey.
Shane Bailey previously worked as Associate Director of Global Quality and Regulatory Affairs at Bend Bioscience Formerly Corerx and Regulatory Affairs Manager at Corerx, Inc.. Shane Bailey holds Master Of Pharmacy, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs from University Of Florida.
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Bend Bioscience
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Profile bio
About Shane Bailey
At Bend Bioscience, my focus is on leading regulatory activities that align with international requirements, ensuring that our products meet the highest standards of quality and compliance. My role involves managing regulatory affairs for both commercial projects and those under development, with an emphasis on meticulous risk analysis and timeline management. Collaborating across continents, I liaise with regulatory counterparts to support our global initiatives, and I'm the key point of contact for regulatory agency interactions. My expertise in Quality Risk Management and familiarity with ICH guidelines underpin the strategic direction I provide, ensuring that Bend Bioscience's products are compliant and competitive on a worldwide scale.
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Shane Bailey's current company
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9 roles
Shane Bailey work experience
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Associate Director Of Global Quality And Regulatory Affairs
Current
Bend Bioscience Formerly Corerx
Lead regulatory activities in line with US, European, ICH, and other applicable requirements to ensure compliance.Manage the day-to-day regulatory activities for all commercial projects, as well as those projects that are currently in development.Determine and communicate appropriate risk analyses and timeline development.Support the global initiatives for.
Aug 2021 - Present
Jun 2020 - Aug 2021
Director Quality And Regulatory Affairs
- Responsible for alll Quality Activities including but not limited to documentation control, change control, validation, deviation approval, investigation approval, material and component testing and acceptance or.
- Provided overall corporate compliance and regulatory affairs direction and strategic guidance for the US, Canada and Puerto Rico markets.
- Responsible for keeping management team informed of significant changes in federal and local regulations and guidance policies and potentially significant compliance issues; maintaining issue elevation program; and.
- Worked as an active member of Senior Management, including business acquisitions and product development
- Worked as Compliance Director for R&D
- Strategically navigated product transfer due to critical production work stoppage
Nov 2018 - May 2020
Regulatory Affairs Specialist
- Regulatory and Compliance Specialist ensuring quality and compliance with applicable regulatory agencies.
- Leading interactions with regulatory agencies (FDA, DEA, FDBPR)
- Adherence to all company procedures
- Performing and participating in regulatory and client audits.
- Managing Quality Agreements
- Identifying and remediating regulatory risks.
Apr 2016 - Oct 2018
Director Quality Assurance And Regulatory Affairs
- Develop and manage standard operating procedures for pharmaceutical development
- Train staff for FDA compliance and State regulations
- Serve as corporate liaison for compliance audits
- Audit third party manufacturers for contract manufacturer organizations both domestically and internationally
- Assessment and development of corporate strategy for product lines
- Assist international affiliates with global regulatory drug development strategy
Mar 2014 - Apr 2016
Director Of Development And Project Management
Wellflorida Council, Inc
- Expanded service area and incorporated new services to meet clients’ needs
- Performed research, evaluation, and implementation of health planning activities
- Managed and monitored Federally Qualified Health Center grants for HRSA
- Managed fulltime, part-time, and contract employees for ongoing projects
- Created budgets, work plans, and scope of services for new customers
- Assisted with the Florida Pharmacy Almanac Project with the University of Florida Department of Pharmacy
Feb 2005 - Mar 2014
Public Health Representative
Chattanooga Hamilton County Health Department
- Performed tracking, interviewing, and case reporting for newly diagnosed clients with infectious diseases.
- Monitored and evaluated local community grants for preventative disease management including forecasting, budgeting, and accounting standards
- Provided teaching and training programs on diversity, preventative health, and resource management including financial, human resource, and managerial training
- Assessed, planned, implemented and evaluated projects for preventative health agencies to improve health outcomes
- Reviewed, monitored, and evaluated grants on local and national levels totaling $1.5 million
- Developed and implement NACO award winning online outreach program
Feb 2002 - Feb 2005
Health Educator
Knox County Health Department
- Managed Regional Advisory Committee on HIV prevention grants management & needs assessments
- Managed subordinate staff for health services and regional committees
- Collaborated with community-based organizations to ensure a population-based healthcare approach to reduce health disparities and increase health care access
- Established evaluation tools for health disparities initiatives
- Created, managed, and established 501c3 Coalition to address health disparities
- Monitored and evaluated grants for local health organizations
Jan 1999 - Feb 2002
3 education records
Shane Bailey education
Master Of Pharmacy, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs
University Of Florida
Master Of Business Administration (M.B.A.), Health/Health Care Administration/Management
University Of Phoenix
Bachelor Of Science (Bs), Public Health
East Tennessee State University
FAQ
Frequently asked questions about Shane Bailey
Quick answers generated from the profile data available on this page.
What company does Shane Bailey work for?
Shane Bailey works for Bend Bioscience.
What is Shane Bailey's role at Bend Bioscience?
Shane Bailey is listed as Associate Director of Global Quality and Regulatory Affairs at Bend Bioscience.
Where is Shane Bailey based?
Shane Bailey is based in Tampa, Florida, United States while working with Bend Bioscience.
What companies has Shane Bailey worked for?
Shane Bailey has worked for Bend Bioscience, Bend Bioscience Formerly Corerx, Corerx, Inc., Wellspring Consumer Healthcare, and Virtus Pharmaceuticals.
How can I contact Shane Bailey?
You can use AeroLeads to view verified contact signals for Shane Bailey at Bend Bioscience, including work email, phone, and LinkedIn data when available.
What schools did Shane Bailey attend?
Shane Bailey holds Master Of Pharmacy, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs from University Of Florida.
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